Associate Director, Regulatory Affairs Project Planning & Coordination
Acadia Pharmaceuticals
16 days ago
Remote friendly (South San Francisco, CA)
United States
Corporate Functions
Position Summary
Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices for the Global Regulatory Affairs department’s strategic execution. Plans include regulatory submission timelines, compliance and maintenance activities, and department conduct.
Primary Responsibilities
- Develop and maintain integrated regulatory project plans for global submissions, health authority interactions, and key regulatory activities
- Establish and oversee a Health Authority commitment tracker across pre- and post-approval portfolio
- Coordinate governance processes and the cadence of regulatory strategy reviews and endorsements
- Design, implement, and maintain regulatory dashboards and scorecards for visibility, risk identification, and proactive planning
- Develop and manage a clinical trial public disclosure tracker and lead periodic cross-functional status reviews
- Support meeting planning, materials, and bi-annual in-person meeting coordination
- Partner with R&D initiative leaders to ensure regulatory alignment and track deliverables
- Support preparation, maintenance, and review of documentation supporting regulatory development and marketing applications, including SOP review
- Other duties as assigned
Education/Experience/Skills
- Bachelor’s degree in life science, healthcare, or related field
- Minimum 8 years of regulatory drug development experience in pharmaceuticals (or related industry)
- Demonstrated experience supporting global regulatory submissions and health authority interactions
- Willingness and ability to travel domestically and internationally
Benefits (if applicable)
- Discretionary bonus and equity awards
- Salary range: $154,000—$193,000 USD
- Medical, dental, and vision insurance; employer-paid life/disability/business travel/EAP
- 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan (2-year lock-in)
- 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance
Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices for the Global Regulatory Affairs department’s strategic execution. Plans include regulatory submission timelines, compliance and maintenance activities, and department conduct.
Primary Responsibilities
- Develop and maintain integrated regulatory project plans for global submissions, health authority interactions, and key regulatory activities
- Establish and oversee a Health Authority commitment tracker across pre- and post-approval portfolio
- Coordinate governance processes and the cadence of regulatory strategy reviews and endorsements
- Design, implement, and maintain regulatory dashboards and scorecards for visibility, risk identification, and proactive planning
- Develop and manage a clinical trial public disclosure tracker and lead periodic cross-functional status reviews
- Support meeting planning, materials, and bi-annual in-person meeting coordination
- Partner with R&D initiative leaders to ensure regulatory alignment and track deliverables
- Support preparation, maintenance, and review of documentation supporting regulatory development and marketing applications, including SOP review
- Other duties as assigned
Education/Experience/Skills
- Bachelor’s degree in life science, healthcare, or related field
- Minimum 8 years of regulatory drug development experience in pharmaceuticals (or related industry)
- Demonstrated experience supporting global regulatory submissions and health authority interactions
- Willingness and ability to travel domestically and internationally
Benefits (if applicable)
- Discretionary bonus and equity awards
- Salary range: $154,000—$193,000 USD
- Medical, dental, and vision insurance; employer-paid life/disability/business travel/EAP
- 401(k) match 1:1 up to 5%; Employee Stock Purchase Plan (2-year lock-in)
- 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance